Impact and Cost-effectiveness of Safer Conception Strategies for HIV Prevention

描述(由申请人提供)：艾滋病毒预防的更安全概念战略的影响和成本效益这个有指导的研究项目将调查艾滋病毒预防研究中被忽视的一个紧迫的公共卫生问题：希望怀孕的艾滋病毒携带者夫妇的生殖需求。在整个撒哈拉以南非洲，绝大多数艾滋病毒感染者是处于生育年龄的成年人。艾滋病毒预防文献几乎完全侧重于在提倡100%使用避孕套的背景下防止艾滋病毒性传播的战略，这与怀孕不相容，以及在怀孕后预防艾滋病毒的战略，例如，防止在怀孕、分娩和分娩期间或母乳喂养期间从母亲传染给孩子。虽然已经发表了几篇关于安全概念和艾滋病毒预防的综述，最近也制定了临床指南，但还没有系统的研究来检查不同的安全概念策略的成本、潜在影响和成本效益，或实际的偏好。我提出的有指导的研究计划将解决艾滋病毒预防研究中的这一关键差距。它由两个阶段组成：第一阶段是在肯尼亚试点测试SAFER概念指南的小型混合方法示范项目；第二阶段是估计成本并对指南的潜在影响和成本效益进行建模的研究。这些阶段将解决以下目标：(1)实施混合方法示范项目，以(I)表征对不同SAFER概念战略的遵守和偏好，以及(Ii)估计必要的参数，以模拟和设计在这种背景下组合SAFER概念计划的影响和设计大规模评估。我将与肯尼亚研究团队一起，使用定量和定性方法来表征不同SAFER概念策略的接受度、依从性以及患者和提供者的偏好，并生成对过程和影响结果的关键初步估计，以及结果的临床间变异性。这项工作的结果将为目标2和目标3奠定基础；(2)估计成本，并为肯尼亚尼安萨省艾滋病毒携带者夫妇更安全受孕的不同战略的影响和成本效益建立模型。我将在实施示范项目期间进行“微观成本计算”以及时间和行动研究，以收集提供更安全的构思选择所需资源的估计。我将利用示范项目的数据和适当的历史队列，模拟在这一背景下不同战略的安全受孕干预措施在不和谐夫妇中预防艾滋病毒的潜在影响和成本效益；(3)制定一项组合安全受孕干预措施的初步计划，以防止Nyanza艾滋病毒不和谐夫妇中艾滋病毒的传播。在与当地利益攸关方的参与性研讨会上，我们将对研究结果进行批判性评估，确定潜在的挑战，定义更安全的概念干预方案，并制定干预计划。在第四年，我将向美国国立卫生研究院提交一份R系列申请，进行一项大规模研究，以确定干预的影响并估计其成本效益。

DESCRIPTION (provided by applicant): Impact and Cost-effectiveness of Safer Conception Strategies for HIV prevention This mentored research project will investigate an urgent public health problem that has been neglected in HIV prevention research: the reproductive needs of HIV-discordant couples who desire pregnancy. Across sub-Saharan Africa, the vast majority of HIV-infected individuals are adults of reproductive age. The HIV prevention literature has almost exclusively focused on strategies to prevent sexual HIV transmission in the context of promoting 100% condom use, which is not compatible with conception, and strategies to prevent HIV after conception has occurred, e.g., prevention of transmission from mother to child during pregnancy, labor and delivery, or breastfeeding. While several reviews on safer conception and HIV prevention have been published and clinical guidelines have recently been developed, there has been no systematic research to examine the costs, potential impact and cost-effectiveness, or actual preferences for different strategies of safer conception. My proposed mentored research plan will address this critical gap in HIV prevention research. It is comprised of two phases: the first phase a small mixed methods demonstration project to pilot test the safer conception guidelines in Kenya; and the second, a study to estimate costs and model the potential impact and cost- effectiveness of the guidelines.These phases will address the following aims: (1) Conduct a mixed-methods demonstration project to (i) characterize adherence to and preferences for different safer conception strategies, and (ii) estimate parameters necessary to model the impact of and design a large-scale evaluation of a combination safer conception program in this setting. I will, with a Kenyan research team, use quantitative and qualitative methodologies to characterize uptake, adherence to, and patient and provider preferences for different safer conception strategies, and generate critical preliminary estimates of process and impact outcomes, and inter-clinic variability in outcomes. The findings from this work will lay the groundwork for Aims 2 and 3; (2) Estimate the cost, and model the impact and cost-effectiveness of different strategies for safer conception for HIV-discordant couples in Nyanza Province, Kenya. I will carry out "micro- costing" and time and motion studies during the implementation of the demonstration project (above) to gather estimates on resources required for providing safer conception options. I will use data from the demonstration project and appropriate historical cohorts to model the potential impact and cost-effectiveness of different strategies of safer conception interventions for HIV prevention among discordant couples in this setting; (3) Develop a preliminary plan for a combination safer conception intervention to prevent HIV transmission among HIV discordant couples in Nyanza. In participatory workshops with local stakeholders, we will critically evaluate the research findings, identify potential challenges, define the safer conception intervention package, and develop an intervention plan. In year 4, I will submit an R-series application to the NIH for a large-scale study to determine the impact and estimate the cost-effectiveness of the intervention.